In section, 4.4 (Special warnings and precautions for use), the word "pharmacist" has been deleted from the following paragraphs:
As weight loss may be accompanied by improved metabolic control in diabetes, patients who are taking a medicinal product for diabetes should consult a doctor or pharmacist before starting treatment with alli, in case it is necessary to adjust the dose of the antidiabetic medicinal product.
Patients who are taking amiodarone should consult a doctor or pharmacist before starting treatment with alli (see section 4.5).
The following has been added to section 4.4.
Patients with kidney disease should consult a doctor before starting treatment with alli, as the use of orlistat may rarely be associated with hyperoxaluria and oxalate nephropathy.
Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are co-administered (see section 4.5). Patients taking levothyroxine should consult a doctor before starting treatment with alli, as orlistat and levothyroxine may need to be taken at different times and the dose of levothyroxine may need to be adjusted.
Continued...
Patients taking an antiepileptic medicinal product should consult a doctor before starting treatment with alli, as they should be monitored for possible changes in the frequency and severity of convulsions. If this occurs, consideration could be given to administering orlistat and antiepileptic medicinal products at different times (see section 4.5).
In section 4.5 (Interaction with other medicinal products and other forms of interaction), the following has been added:
Levothyroxine
Hypothyroidism and/or reduced control of hypothyroidism may occur when orlistat and levothyroxine are taken at the same time (see section 4.4). This could be due to a decreased absorption of iodine salts and/or levothyroxine.
Antiepileptic medicinal products
Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic medicinal products e.g. valproate, lamotrigine, for which a causal relationship to an interaction cannot be excluded. Orlistat may decrease the absorption of antiepileptic medicinal products, leading to convulsions.
In section 4.5 (Interaction with other medicinal products and other forms of interaction), the word "pharmacist" has been deleted from the following paragraph.
A decrease in plasma levels of amiodarone, when given as a single dose, has been observed in a limited number of healthy volunteers who received orlistat concomitantly. The clinical relevance of this effect in patients receiving amiodarone treatment remains unknown. Patients who are taking amiodarone should consult a doctor or pharmacist before starting treatment with alli. The dose of amiodarone may need to be adjusted during treatment with alli.
In section 4.8 ( undesirable effects) pancreatitis and Renal and urinary disorders have been added.
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Gastrointestinal disorders
Very common:
Common:
Not known:
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Oily spotting
Flatus with discharge
Faecal urgency
Fatty oily stool
Oily evacuation
Flatulence
Soft stools
Abdominal pain
Faecal incontinence
Liquid stools
Increased defaecation
Diverticulitis
Pancreatitis
Mild rectal bleeding (see section 4.4)
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Renal and urinary disorders
Not known:
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Oxalate nephropathy
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